Thrombolysis catheter system with fixed length infusion zone

ABSTRACT

A thrombolysis catheter system having a fixed length infusion zone is disclosed. The invention contemplates apparatus, method and kit aspects. The apparatus, which has the capability to track a guidewire, uses a multilumen catheter to deliver radially thrombolytic agent to an infusion zone defined by one or more balloon means. In one aspect, with an occluder means, a primary lumen of the catheter is used both for catheter placement and delivery of fluid. The method discloses utilization of radiopaque indicia to place the catheter in proximity to the occlusion or diseased tissue to be treated. The kit includes a catheter of the invention in conjunction with a steerable guidewire and a tip occluder wire, either or both of the tip occluder wire and the guidewire having an enlargement on their distal tip which cooperates with a reduced diameter portion of the catheter lumen.

This is a continuation application of Ser. No. 08/101,989 filed Aug. 4,1993, now U.S. Pat. No. 6,113,576.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to devices used to clear obstructionsin body passageways, more particularly, this invention relates toapparatuses and methods of treating such obstructions by the infusion ofchemical thrombolytic agents. Yet more particularly, this inventionrelates to catheters and to catheter systems for exposing vascularobstructions to therapeutic agents, generally to effectuate theirremoval.

2. Description of the Prior Art

The use of catheter systems to treat various medical conditions has beenknown for some time. In treating a particular area within a bodypassageway, it is often desirable to isolate the area to be treated fromthe rest of the body. One approach to isolating a treatment area is theplacement of one or more inflatable balloons proximal or distal (orboth) to the treatment area. Inflating the balloon or balloons serves toisolate the vascular structure to be treated and permits control of thelength of time of exposure. U.S. Pat. No. 2,936,760 issued to Gants,U.S. Pat. No. 4,022,216 issued to Stevens, and U.S. Pat. No. 4,705,502issued to Patel describe catheters designed for use in the urinarytract.

Catheter systems are also used in other applications. U.S. Pat. No.4,696,668 issued to Wilcox, for example, describes a catheter system fortreatment of nasobiliary occlusions. Similarly, U.S. Pat. No. 4,198,981issued to Sinnreich is used in intrauterine applications. U.S. Pat. No.4,453,545 issued to Inoue discloses an endotracheal tube.

One of the most common applications for catheter systems is thetreatment of occlusions within the cardiovascular system. A cathetersystem for venous applications is seen in U.S. Pat. No. 4,795,427 issuedto Helzel. U.S. Pat. No. 4,636,195 issued to Wollinsky, U.S. Pat. No.4,705,507 issued to Boyles, and U.S. Pat. No. 4,573,966 issued to Welklet al., all describe catheter systems designed to infuse a liquid forthe treatment of an arterial occlusion. Each of these devices has one ormore balloons which can be inflated to occlude the artery during thetreatment process.

U.S. Pat. No. 4,655,746 issued to Daniels et al. discloses the use oftwo concentric catheters defining an interlumenal space therebetween.Each of the catheters has its own balloon to isolate (adjustably) aportion of the body passageway. The Daniels et al. design, however,.requires the use of the interlumenal space as a fluid passageway,thereby complicating the construction and operation of the device.

U.S. Pat. No. 4,927,418 to Dake et al. discloses a catheter for uniformdistribution of therapeutic fluids. The Dake et al. catheter utilizes arelatively thick-walled tubular body having a plurality of smallerlumens therein in conjunction with a larger central lumen dischargingfluid from the catheter.

U.S. Pat. No. 5,059,178 to Ya uses balloons to subtend a blood vesselupstream and downstream of a thrombus. Thrombus dissolving agent issupplied to the zone between the balloons. An expansion catheter havinga third balloon is used to expand a location of structure remainingafter removal of the dissolved thrombus.

BRIEF SUMMARY OF THE INVENTION

The present invention provides an apparatus, a method, and a kit fortreating an obstruction in a body passageway, such as a vein or anartery, through the infusion of a fluid. In one aspect the presentinvention is a catheter for administering therapeutic agent to anobstruction within a vascular system. A catheter of this invention has afixed length infusion zone generally defined by one or more inflatableballoons and a series of infusion orifices located therebetween. Acatheter of this invention comprises a cylindrical catheter body. Thecylindrical catheter body comprises a wall, the wall having distal andproximal ends. One of the distal or proximal segment ends of thecatheter wall body has a balloon means located thereon. The wall furtherincludes or defines a plurality of radial orifices.

The catheter body also interiorly defines a primary lumen, the primarylumen extending through the catheter body to couple, fluidically, theorifices and its distal and proximal ends. The primary lumen has alarger diameter segment beginning adjacent the proximal end of thecatheter and extending the majority of the length of said catheter body,and a smaller diameter segment located interiorly adjacent the distalend of the catheter body and distal to the orifices. The reduceddiameter segment of the primary lumen is adapted to cooperate with aseparate occluder means (described below) to restrict fluid flow out thedistal end of the first lumen and to force such fluid to flow radiallyfrom the orifices.

The diameter of the primary lumen, with the exception of the extremedistal portion, is in the range of about 0.16 inches to about 0.065inches while the diameter of the smaller diameter segment is in therange of about 0.014 inches to about 0.060 inches.

The catheter body of a catheter of this invention, preferably, alsodefines at least a second lumen, the second lumen being in fluidcommunication with the balloon means and the proximal end of thecatheter body so as to permit said balloon means to be inflatedtherefrom.

The diameter of said plurality of second lumens is in the range of about0.009 inches to about 0.025 inches.

In a preferred practice of this invention, two balloons are used toisolate the treatment area from the remainder of the body so thattherapeutic agent may be infused therearound. One of each of theballoons is located on the catheter wall upstream and downstream of theinfusion ports.

In another aspect, the present invention is a method of treating anobstruction, such as thrombus, within a vascular structure. (Thelocation of the obstruction has been previously identified by methodswell known to this art.) A method according to this invention comprisesthe steps of first advancing a steerable guidewire through thevasculature until the distal tip thereof is adjacent i.e., in thevicinity or proximate to, the previously located obstruction or diseasedsegment to be treated. Next, a catheter having a structure as describedabove is advanced or slid over the guidewire until the infusion zone islocated at the treatment site. At this juncture, the spatialrelationship between the obstruction and the catheter/guidewirestructure will determine the next step. If the steerableguidewire/catheter combination/structure cannot be positioned throughthe obstructed segment, then the guidewire is removed from the catheterand an occlusion means, occlusion wire, or tip occluder wire, isadvanced through the primary lumen thereof. If the catheter/guidewirecombination structure can be passed through the vascular obstruction,utilization of the steerable catheter guidewire/conbination continues.While utilization of the steerable wire is preferred, a non-steerabletip occluder wire permits the extreme distal portion of the catheter tobe positioned more closely to, for example, thrombus which cannot becrossed with a steerable wire. Withdrawing a steerable guidewire intothe catheter body, which would permit the catheter to be positioned moreclosely to the treatment site, tends to restrict radial fluid deliverydue to restriction of diameter of the primary lumen. Both the steerableguidewire and the occlusion means or tip occluder wire have anenlargement adjacent their distal ends which cooperate with the reduceddiameter portion of the primary lumen substantially to prevent fluidfrom passing distally from the catheter.

Whether the tip occluder or steerable guidewire is used, the next stepis to inflate the balloon means to define the treatment area. Lastly,thrombolytic agent is introduced into the primary lumen and subsequentlyexits or infuses from the radial passages to the infusion zone to treatthe obstruction.

In a preferred practice of this method, the catheter includes aplurality of balloons located distally and proximally with respect tothe orifices. The balloons are fluidically coupled to the proximal endof the catheter by means of secondary lumens which permit the balloonsthereby to be inflated and deflated. Thrombolytic agents may includeurokinase, streptokinase, tissue plasminogen activator (TPA), or asimilar therapeutic species. As the lesion within the treatment area isexposed to the thrombolytic agent, some of the material is dissolved andis removed therefrom.

In a preferred practice of the above method, a radiopaque structure onthe catheter, usually on its distal segment, is monitored while thecatheter is positioned within the vasculature. A plurality of radiopaquestructures, such as platinum rings or bands, may be disposed along thelength of the catheter, and on the steerable guidewire and on theoccluder wire. These structures appear more intense than adjacent,non-radiopaque materials under fluoroscopic examination. Generally, asteerable guidewire will have a radiopaque distal tip and possiblyadditional proximally-located radiopaque structures. By observation ofthese radiopaque structures, the progress of the catheter into thevasculature can be observed, the location of the balloon or balloons(and therefore the infusion zone) relative to the treatment site can bedetermined, and the relationship between the catheter and the guidewireor occluder wire can be monitored. Utilization of the cooperativelylocated radiopaque structures in catheter placement and in therapeuticapplication is a particularly advantageous aspect of the presentmethods.

Yet a further aspect of this invention comprises a kit. A kit of thisinvention comprises an occluder means such as a tip occluder wire havingan enlargement adjacent its distal end and a steerable guidewire. Theguidewire preferably has an enlargement adjacent its distal end, therebyincorporating the features of both a steerable guidewire and anon-steerable occluder wire. The diameter of the enlargement of eitheror both of the guidewire or occluder wire is determined by the interiordiameter of the reduced diameter segment of the primary lumen of thecatheter. A kit having at least the above three components offersmedical personnel employing a catheter of this invention the ability tomaximize their options with respect to patient treatment. Kit componentsmay include other necessary or desirable equipment such as stopcocks,syringes and gloves.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects of the present invention and many of the attendantadvantages of the present invention will be readily appreciated as thesame become better understood by reference to the following detaileddescription when considered in connection with the accompanyingdrawings, in which like reference numerals designate like partsthroughout the figures thereof and wherein:

FIG. 1 is a plan view of a catheter of the present invention;

FIG. 2 is a plan view of a second embodiment of a catheter of thepresent invention;

FIG. 3 is a view of a catheter of this invention with an infusion zoneproximal to the balloon;

FIG. 4 is a view of a catheter of this invention with an infusion zonedistal to the balloon.

FIG. 5 is a sectional view of the catheter body taken alone line 5—5 ofFIG. 1;

FIGS. 6, 7 and 8 are sectional views of the catheter body distal segmenttaken along lines 6—6, 7—7, and 8—8, respectively.

FIG. 9 is a perspective view of the proximal end connector of a catheterof this invention;

FIG. 10 is a view of the proximal end connector of FIG. 9 with parts cutaway and shown in section;

FIGS. 11, 12, and 13 are sectional views of the proximal end connectorof FIG. 9 taken along lines 11—11, 12—12 and 13—13, respectively, ofFIG. 9;

FIG. 14 is a perspective view of a proximal end connection forconnecting a catheter of the invention with an external source of fluidwith which to inflate distal end balloons;

FIG. 15 is a view of a proximal end connector for fluid for connecting acatheter of this invention to an external source of fluid with which totreat thrombus;

FIG. 16 is a sectional detail of the connector of FIG. 14;

FIG. 17 is a schematic depiction of a steerable guidewire useable withthis invention.

FIG. 18 is a schematic depiction of a tip occluder wire in accordancewith this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is a plan view of a thrombolysis catheter or catheter system 10of the present invention. Catheter 10 comprises a cylindrical catheterbody 12. Catheter body 12 is flexible so as to be able to negotiatetortuous vascular structures and has distal and proximal ends 14, 16respectively. For purposes of reference herein, the terms “distal” and“proximal” are determined from the frame of reference of a user. Thus a“proximal” structure or indication tends to be located closer to theuser. Catheter body 12 has therein (and defines) a plurality of radialorifices 18. Catheter body 12 also has located on its external surfaceproximal and distal balloons 20, 22, respectively. Balloons 20, 22 areshown in their deflated state, i.e., substantially as they would appearas the catheter is being deployed within a patient's vasculature.

Between balloons 20, 22 is an infusion zone or operating segment 24.Infusion zone 24 is the working or operating portion of the cathetersystem of this invention in the sense that, after vascular manipulationand positioning, this portion of the system will be located adjacent therestriction or occlusion to be treated. Generally this will mean thatthe operating segment of the catheter will be located upstream from, oracross (through) the restriction. Illustrating this practice of theinvention, balloons 20, 22 will be located upstream and downstream,respectively, of the occlusion or tumorous structure to be treated, if acatheter system having two balloons is utilized.

Also illustrated in FIG. 1 is an optional radiopaque marker band 26.Marker band 26 generally comprises a substantially radiopaque materialsuch as platinum and platinum alloys. Marker band 26 is disposed on thedistal end 14 of the catheter body 12 so that it can be observedfluoroscopically during catheter placement. In this manner, attendingmedical personnel can determine where catheter distal segment 14 islocated relative to the previously identified site of the vascularobstruction. Moreover, depending upon the application, a plurality ofmarker means or marker bands may be employed, to provide even moreinformation to attending medical personnel as to where various catheterstructures are located within the vasculature. For example, marker bands27 and 29 (shown in phantom in FIG. 1 because they are beneath theballoons) indicate the approximate positions of proximal and distalballoons 20, 22.

Radiopaque marker bands may be flush with the external surface ofcatheter body 12 or they may lie above or within it. The proximal end 16of catheter body 12 is coupled to a trilumen connector 28 the details ofwhich are more completely discussed below. Trilumen connector 28 iscoupled to catheter body proximal end 16 via strain reliever 30.Connector 28 couples to a plurality of luer stopcock connectors 32, 34which are fluidically connected, via tubes 33, 35 and catheter bodyluminae, to balloons 20, 22. Axial luer port connector 36 is coupled(via tube 37) to catheter body 12 and, in turn, to its principal lumen,the details of which are discussed below.

FIG. 2 illustrates an embodiment of the invention in which there is asingle proximal balloon 20. Located distally with respect to proximalballoon 20 is infusion zone 24′. Infusion zone 24′, in this embodiment,includes radiopaque marker band 26 which generally indicates one of itsedges. Infusion zone 24′ has no distally located balloon and thereforhas only a single luer coupler 34. Further, the catheter of FIG. 2 has abilumen connector 38 which fluidically couples to catheter body 12.Infusion zone 24′, in this embodiment, is relatively short. Infusionzones generally have a length in the range of about ½ inch to about 10inches. The length of the infusion zone selected will depend upon theintended therapy, the number of orifices, the therapeutic agent to beinfused, the intended infusion rate, whether one or two balloons are tobe employed on the catheter, and the extent to which distal migration ofthrombolytic agent/dissolution products is to be permitted.

FIG. 3 illustrates a catheter of this invention substantially the sameas FIG. 2 but having a substantially longer infusion zone 24″.

FIG. 4 illustrates an embodiment of the invention 10′″ in which a singleballoon 22′ is located distally, i.e., downstream, with respect toinfusion zone 24′″. The following edge or proximal limit of infusionzone 24′ is shown as a dotted line because the proximal limit is notmore precisely defined by a proximal balloon. In other words, theproximal limit or edge of infusion zone 24′″, in this embodiment 10′″,with only a distal balloon 22′ will lie upstream of orifices 18 but willnot be as precisely defined as if two balloons were utilized. Radiopaqueproximal marker band 29 indicates, under fluoroscopic observation, theapproximate proximal or upstream limit of infusion zone 24′″.

FIG. 5 is a detailed sectional view of the embodiment of FIG. 1 takenalong line 5—5 of FIG. 1. Catheter body 12 is shown to have a catheterbody wall 40. Catheter body wall 40 defines a slightly off-axisprincipal lumen 42. Catheter body wall 40, in this embodiment, definestwo additional smaller diameter secondary lumens 44, 46 one of which isshown in phantom in FIG. 5 and both of which are better shown in FIGS.6-8. Proximal and distal balloons 20, 22 are exteriorly affixed tocatheter wall body 40, e.g., by adhesive indicated at 48. Orifice 18 isshown to be in communication with principal lumen 42 so that fluid inputfrom the proximal end of the device (generally to the left in FIG. 5),after passing through principal lumen 42 would be radially dispensedtherefrom. Distal, medial and proximal radiopaque marker bands 26, 27and 29, respectively, are externally disposed on catheter body wall 40so that the tip of the device and the balloon locations can all befluoroscopically monitored during catheter system placement andutilization.

Principal lumen 42 has a larger diameter, proximal segment 54 and asmaller diameter, distal segment 56′. Smaller diameter principal lumensegment 56 is of a size such that an occluder segment or a steerableguidewire can be inserted therein and substantially stop proximal fluidflow out catheter body distal end 14. By passing, for example, annon-steerable occluder wire or a steerable guidewire having anenlargement down principal lumen 42, lumen 42 is occluded and distalfluid flow prevented. This forces fluid entering principal lumen 42 atcatheter body proximal end 16 to exit radially from, e.g., orifice 18.In this manner, catheter system 10 can be directed to the site of avascular occlusion and (after inflating the balloons) thrombolytictreatment applied.

Principal lumen reduced diameter segment 56, as shown, begins to taperin diameter at about the leading edge 57 of distal balloon 22. Reductionor tapering in diameter permits a larger range of occluder wire orguidewire enlargements to be employed. Also, if a guidewire or occluderwire enlargement is somewhat compressible, a more fluid-tight fit can beformed with the tapering lumen interior wall.

FIGS. 6, 7, and 8 illustrate the internal details of catheter body 40which define some of the important features of this invention. Deflateddistal balloon 22 and proximal balloon 20 are shown in FIGS. 6 and 8,respectively. Such balloons would be fashioned from a stretchable,inflatable material such as latex. By means of an opening or skive 58,distal balloon 22 is in fluid communication with secondary lumen 46.Proximal balloon 20 is in fluid communication with secondary lumen 44via a second proximal skive 60. Secondary lumens 44 and 46 are in fluidcommunication with catheter proximal end 16 so that, by means ofproximal valves or couplers, discussed in greater detail below, theballoons may be separately and independently inflated and deflatedtherefrom, e.g., with external fluid sources.

Skives 58 and 60 may be simply cut or drilled into catheter body wall40. Principal lumen 42 and secondary lumens 44, 46 may be simultaneouslyformed, e.g., by extrusion of catheter body 12 of a thermoformingpolymeric material. Various catheter body materials have been found tobe usable to produce catheter bodies. Extrudable polyester elastomermaterials as well as vinyl polymer materials are preferred.

FIGS. 9 and 10 illustrate in plan view and in partial sectional view,the details of trilumen connector 28. Trilumen connector 28 is disposedadjacent the proximal end of catheter body 12. As shown in the externalview of FIG. 9, trilumen connector 28 comprises a triangularly shapedconnector body 62. Connector body 62 may be planar (as shown) or it maybe curvilinear with the axes of the lumens being non-planar. Connectorbody 62 couples with catheter body 12 by means of strain reliever 30.Connector body 62 has molded or machined therein three separate channels64, 66, and 68 respectively. Channels 64, 66, and 68 are coupled toinput tubes 33, 35 and 37, respectively. While the coupling of inputtubes 33, 35 and 37 with respect to channels 64, 66 and 68 is notcritical, as shown, tube 33 leads to channel 64, tube 35 leads tochannel 66, and tube 37 leads to channel 68.

FIGS. 11, 12 and 13 are sectioned views of triangular connector 62 takenalong lines 11—11, 12—12, and 13—13, respectively. FIG. 11 illustratesthat tubes 33, 35 and 37 are secured to the inside walls 76, 78 and 80,respectively, of channels 66, 64, and 68, respectively.

FIG. 12 illustrates the molded internal configuration of channels 64,66, and 68. Channel 64 is coupled to principal lumen 42 whereas channels66 and 68 are coupled to secondary lumens 42 and 44, respectively.

FIG. 13 illustrates the details of connection between the principal andsecondary lumens through strain relief 30. An optional shoulder 80 ismolded into the narrower end of connector body 28. As shown, trilumencatheter body wall 40 is encircled by strain relief 30 and in turnmerges into the small end of triangular connector body 62.

FIGS. 14 and 15 illustrate perspective views of luer stopcock connector34 as well as luer port connector 36. By means of valve or stopcock 84,luer connector 34 can be used to control fluid input and thereby controlinflation and deflation of one or more balloons. Fluid is input atorifice 86 from an external source of fluid which is not shown.Generally speaking, an incompressible fluid such as saline solution willbe utilized to inflate and control the radial dimension of balloonsdisposed on catheter body 12.

FIG. 15 illustrates a luer fitting connector 36 which permitsthrombolytic fluid input as well as insertion of an occlusion means suchas a tip occluder wire or a steerable occlusion wire (e.g., a guidewire)into primary lumen 42. The connector illustrated in FIG. 15 will becoupled to principal lumen 42 and, in turn, to all radial orifices 18 aswell as the extreme distal end 14 of the catheter.

FIG. 16 illustrates in section the details of luer stopcock connector34. As shown, valve or stopcock 84 has a transverse channel 88 which,when connected, can be used to control fluid input and output toballoons 20, 22 depending upon which lumen the luer stopcock connector34 is connected.

As noted above, one aspect of this invention is a kit, the kit includinga catheter as described above, a steerable guidewire alone or incombination with a non-steerable occluder wire. Steerable guidewires arewell known to those skilled in the art of catheter utilization and willnot be discussed in detail here. Particularly desirable steerableguidewires useable with the catheter described herein are commerciallyavailable from Lake Region Manufacturing of Chaska, Minnesota. Generallyspeaking, a guidewire useable with the present catheter comprises astainless steel wire body and a coil spring distal tip. Useablesteerable guidewires also preferably have coatings of Teflon PTFE orsilicone (or both).

FIG. 17 shows schematically a preferred structure of a steerableguidewire 100 usable with the present catheter. Guidewire 100 comprisesa stainless steel core wire body 102 having a distal coil 104 (shown inpartial section) on the end thereof. Core wire body 102 terminates in anatraumatic distal tip 106 which optionally may be made of a radiopaquematerial. A proximal radiopaque marker band 107, e.g., on the proximalend of coil 104, may be included in the structure depending upon userpreference. Beneath coil 104 and located adjacent distal tip 106additional radiopaque markers or radiopaque indicia, e.g., a radiopaquewire segment 108, may be included.

A kit of this invention can also include an occluder wire or cathetertip occluder. As described above, the tip of an occluder wire isenlarged to cooperate with the tapered or reduced diameter segment ofthe catheter body principal lumen to restrict distal fluid delivery andto force fluid infusion from radial orifices or side ports 18. Anoccluder wire usable with this invention will generally comprise astainless steel wire body with a ball or enlargement formed or brazed toor proximate to its distal end. Diameters of the wire body may rangewidely from approximately 0.009 in. to about 0.018 in. Length also mayvary from approximately 80 to 160 cm. The diameter of the stainlesssteel wire body should be small relative to the diameter of the primarylumen to provide more space for fluid to be infused therearound when theoccluder wire is in position. A tip occluder wire will, generallyspeaking, not be steerable and will not normally be intended to exit thedistal end of the catheter. As discussed above, this permits a catheterin which a tip occluder is used to be positioned closer to anobstruction.

A kit of this invention may also include an extension wire or anexchange wire. An extension wire is used, for example, to extend analready positioned guidewire (i.e., positioned within the vasculature)to facilitate catheter exchange. Extension wires generally comprisestainless steel and include a docking or mating distal segment whichcooperates with a mating segment on the proximal end of the guidewire.While the docking or guidewire extension system utilized is not criticalto this invention, a particularly desirable guidewire extension systemis commercially available from the Lake Region Manufacturing Company ofChaska, Minn., U.S.A. The primary limitation on guidewire/extension wiredocking systems selection is that catheter exchange over the extendedwire must be easily and quickly accomplished.

Lastly, depending upon the application and user preference, a kit ofthis invention may include various other components. For example, aTouhy-Borst “Y” Adaptor may be included. The hemostasis valve of such anadaptor prevents possible catheter leakage with a guidewire or occluderwire in place in the catheter. Touhy-Borst “Y” Adaptors are commerciallyavailable from several manufacturers. The kit may also include syringes(i.e., to be used to inflate the balloon or balloons), gloves, topicalanesthetics and other equipment as needed for the application.

Various modifications and alterations of this invention will becomeapparent to those skilled in this art from the above disclosure. It willbe understood that all such variations and modifications within thespirit and scope of this invention are included within the scope of theattached claims.

What is claimed is:
 1. The method of treating thrombus within apatient's vascular system comprising the steps of: a. advancing aguidewire through the patient's vasculature and positioning the distalend thereof adjacent the thrombus to be treated; b. advancing a catheterover the guidewire and urging the distal portion of the catheter intothe thrombus, the catheter comprising an elongated tubular body having aprimary lumen for receiving the guidewire and delivering fluid to thethrombus to be treated and having distal and proximal ends, said primarylumen passing through said catheter body and having a reduction indiameter at its extreme distal end to cooperate with an occluder means,the lumen communicating with a plurality of radially directed fluidpassageways which pass through the catheter body so as to deliver fluidtherefrom to the exterior of the catheter, the catheter furthercomprising one or more secondary lumens having a diameter which is lessthan that of the first lumen and which are in fluid communication withballoon means disposed on the exterior of the catheter body; c.positioning the balloon means proximate the thrombus; d. positioning theguidewire within said primary lumen so that said reduced diametersegment cooperates with said guidewire substantially to restrict fluidfrom passing out the distal end of the catheter body; e. inflating saidballoon means; and f. introducing thrombolytic agent into said primarylumen and subsequently through said radial passageways to saidvasculature to treat said thrombus.
 2. A method according to claim 1wherein the balloon means positioning step is accomplished whilefluoroscopically observing radiopaque markings, the catheter havingradiopacity indicia on its body proximate the balloon means and itsdistal tip, and the guidewire having radiopacity indicia on its extremedistal tip, the positioning step creating alignment between theguidewire radiopacity indicia, and the catheter radiopacity indicia tolocate the infusion zone adjacent the thrombus.
 3. The method accordingto claim 1 wherein the method is followed by additional interventionaltherapeutic procedures.
 4. A method according to claim 1 wherein saidcatheter has a central axis and said primary lumen is offset therefrom.5. A method according to claim 1 wherein the diameter of the primarylumen with the exception of the extreme distal portion is in the rangeof about 0.016 inches to about 0.065 inches while the diameter of theextreme distal portion of said primary lumen is in the range of about0.014 inches to about 0.060.
 6. A method according to claim 1 whereinthe diameter of said secondary lumens is in the range of about 0.009inches to about 0.025 inches.
 7. A method according to claim 1 whereinthe cross sectional area of said radial passageways are allsubstantially the same.
 8. A method according to claim 1 wherein thestep of advancing the catheter over the guidewire is accomplished whilemonitoring a radiopacity marker located adjacent the distal portionthereof.